Official figures for sharps injuries (accidental needle or sharp instruments impaling medical or other professionals, who routinely use these devices) are about 800,000 to 1,000,000 reported per year. In light of under-reporting by nurses, physicians and other health care professionals, this number is likely as high as 2 to 3 million per year (in all health care settings). Each year the cost to the medical industry is over $3 billion, for both testing and treating injured health care professionals. Everyday, 9000 health care workers in the United States sustain a disabling injury from sharps (average cost per hospital is greater than $24,000). Average cost per injury is $2500 to $4000. A single sero-conversion of Hepatitis C carries a lifetime cost of greater than $600,000. If the healthcare industry is spending twice the cost (on an injured worker) of the expense to manufacture conventional syringes, it is financially assumable, that safety devices might ultimately be worth the investment. These costs do not even consider the potential legal costs to defend use of a device with no safety mechanism.
In 1999, Federal legislation passed the Needle-stick Safety and Prevention Act, which now requires the OSHA compliance officer to review sharps injuries under the Blood Born Pathogens Standards. This requires employers to establish and maintain a sharps injury log of contaminated sharps which should include: type and brand of device used; department where injury occurred; and explanation of how the incident occurred.
Currently six states have existing needle-stick legislation and many other states have adopted the Federal legislation into their OSHA policies. In February 2000, the obvious legislative interest for improved sharps injury incidence recording was demonstrated by the National Institute of Health grants of $300,000 to improve strategies and methods of detecting and accurately reporting sharps injuries in the health care industry. Additionally OSHA has the authority to levy fines for repeat violations, if facilities fail to have adequate provisions to protect their employees. Regulatory measures regarding all safety devices will likely increase over the next few years secondary to enforced legislation.
Controversy currently exists, with new studies supporting single-use tube holders to avoid contamination with blood during phlebotomy procedures (venous collection of blood). A recent study showed that 83% of randomly selected tube holders showed blood contamination. Simultaneously, “safety syringes” defeat the purpose of the safety design when used for phlebotomy in that, the transfer mechanism to a specimen container introduces an even greater risk to the user. Most sharps injuries are from needle-stick injuries, usually caused by two-handed recapping of the needle after use. Syringes are used in multiple situations: intra-muscular injections, subcutaneous injections, intra-venous (both to administer medications and for phlebotomy), as a support base to place an I.V. catheter and as a direct attachment to I.V. tubing.
Needles are disposed in a specific container designed to be sealed after being filled with sharps. However, there is no standard practice in place for filling the containers. Containers are often irregularly filled with sharps attached to syringes, scalpel blades, lancets and anything deemed appropriate by the health care worker using the container. Needles are often seen protruding through the opening in over-filled containers. This practice, poses a risk to the bio-hazards disposal workers. Needle destruction devices are currently available. Utilization of these devices remains hazardous, as the risk of needle-stick still exists during transport to the device (regardless of destruction of the needle). Much of I. V. therapy is now done with needless systems. However, regardless of needle-less access, the patient has to initially be impaled to acquire the I.V. placement and this requires a needle. Obviously, the same is true of phlebotomy.
The market for syringe/vacutainer devices is thought to be greater than the 12 billion units (worldwide noted in 1996). 85% (approximately 4-5 billion units), of the U.S. market today, continues to be conventional devices (no safety feature). Safety devices (all types), are involved in approximately 15% of the U.S. market today but, evolving legislation will impose a market potential in the next few years of over 10 billion units (if 70-80% of the market demand is met). Currently there are several syringe and needle shields on the market, which claim safety for the intended user. These devices have had some impact on the industry, but continue to be limited because: they require manual intervention, are clumsy (the operator's hand always indirectly approaches the needle), are inconvenient, are not user-obvious, and/or their cost to manufacture is much greater than conventional syringes.
The market has moved slowly in the past, as hospital costs have been scrutinized and controlled by the managed care insurance industry. With legislation now in place imposing liability for the insurance industry, those issues will likely have to be reevaluated in the future. To replace conventional syringes would mean that over 5 billion units already in circulation in the medical, dental and veterinary industry, would likely be recalled (at best) or continue to be used, with the potential risk to the user and liability to the manufacturer.
The ideal solution for the industry would be a product that is easily removed from the sterile packing, is user-obvious, is automatic with single-handed operation, completely encloses the needle after use and locks in place and does not interfere with conventional syringe parameters: clear, easy to read calibrations, any needle size can be used or changed as needed (needle is separate), and is efficiently manufactured, assembled and cost competitive.
The present invention provides for an innovative device which compliments existing technology in that it has the capability of “standing alone” or converting a conventional syringe into a safe, reliable, convenient, automated, single touch, price and assembly competitive, safety syringe. The design allows for prefilled syringes to be converted to safety syringes and when used with an I.V. catheter, it converts routine placement to a safe procedure. The product benefits include: automatic mechanism, fail-proof safety, single handed, user-obvious device, with a low cost to produce. The invention may be used for phlebotomy stations, hospitals, dental, medical and veterinary clinics, physician offices, teaching and research facilities, as well as pre-filled and non-automated existing syringe manufacturer markets.